Reduction of Cerebral Emboli: In vitro Study with a Novel Cerebral Embolic Protection Device.

CEP TAVR cerebral embolic protection device deflection filter in vitro simulator in vitro study trans-catheter aortic valve replacement

Journal

Medical devices (Auckland, N.Z.)
ISSN: 1179-1470
Titre abrégé: Med Devices (Auckl)
Pays: New Zealand
ID NLM: 101566041

Informations de publication

Date de publication:
2020
Historique:
received: 17 10 2019
accepted: 29 02 2020
entrez: 27 3 2020
pubmed: 27 3 2020
medline: 27 3 2020
Statut: epublish

Résumé

To assess the efficacy of the TriGUARD This in vitro study assessed the ability of a cerebral embolic protection device to deflect embolic debris, by measuring the percent of particles and air bubbles, 200 µm and 300 µm in size, from entering the cerebral circulation compared to unprotected controls. A 3D printed silicone model of the ascending aorta, the aortic arch with its three major cerebral arteries and the descending aorta was connected to a custom-made simulator that mimics physiological pulsatile flow patterns of the left ventricle. Comparative analyses were used to assess the efficacy of the cerebral embolic protection device to deflect particles and air bubbles away from the major cerebral arteries. The percent of particles and air bubbles entering the major cerebral arteries was significantly lower with cerebral embolic protection compared to unprotected controls (p<0.0001). Cerebral protection resulted in 97.4-100% reduction in air bubble counts, and 97.4-97.8% reduction in particle counts compared to unprotected controls. This in vitro study used simulated physiologic flow conditions in an aortic arch model to demonstrate >97% efficacy of the TriGUARD

Identifiants

pubmed: 32210643
doi: 10.2147/MDER.S234961
pii: 234961
pmc: PMC7075333
doi:

Types de publication

Journal Article

Langues

eng

Pagination

67-73

Informations de copyright

© 2020 Haiman et al.

Déclaration de conflit d'intérêts

Tamim Nazif reports personal fees, equity from Keystone Heart and Venus MedTech, personal fees from Boston Scientific, outside the submitted work. Alexandra J Lansky reports grants from Yale School of Medicine, during the conduct of the study; Institutional Research support and travel fees from Venous Medical, outside the submitted work. The authors report no other conflicts of interest in this work.

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Auteurs

Guy Haiman (G)

Keystone Heart Ltd., Caesarea, Israel.

Tamim Nazif (T)

Department of Cardiology, Columbia University Medical Center, New York, NY, USA.

Jeffrey W Moses (JW)

Department of Cardiology, Columbia University Medical Center, New York, NY, USA.

Amit Ashkenazi (A)

Keystone Heart Ltd., Caesarea, Israel.

Pauliina Margolis (P)

Keystone Heart Ltd., Caesarea, Israel.

Alexandra J Lansky (AJ)

Division of Cardiology, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
Department of Cardiology, Yale Cardiovascular Research Group, New Haven, CT, USA.

Classifications MeSH